Testing Long-acting Antibodies Alone and Combined for Ulcerative Colitis
Tests long-acting antibody drugs, alone and combined, in adults with moderate to severe ulcerative colitis.
Plain-language title generated from the registry record
Registry title: A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
Key facts
- Where
- Concord, Heidelberg, Liverpool, Melbourne, Murdoch, South Brisbane, and Woolloongabba, AustraliaSee the 7 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderately to severely active ulcerative colitis, confirmed by endoscopy.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Ulcerative colitis diagnosed at least 3 months before Day 1, confirmed by endoscopy and histology. Disease must be moderately to severely active: modified Mayo score of 5-9, rectal bleeding subscore of 1 or more, and Mayo endoscopic subscore of 2 or more. Disease must reach 15 cm (5.9 in) or more from the anal verge, though up to about 15% may have only proctitis.
- Earlier treatment
- People who failed 4 or more approved or investigational advanced therapy classes cannot join.
Main reasons for not taking part
- Current diagnosis of Crohn's disease or IBD-Undefined
- Confirmed or suspected fulminant colitis, toxic megacolon or bowel perforation
- Other conditions likely to need surgery during induction
- Failed 4 or more advanced therapy classes
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07012395, who can take part
Where in Australia
- Concord, New South WalesHospital not named in the registryTaking people
- HeidelbergHospital not named in the registryTaking people
- LiverpoolHospital not named in the registryTaking people
- MelbourneHospital not named in the registryTaking people
- Murdoch, Western AustraliaHospital not named in the registryTaking people
- South Brisbane, QueenslandHospital not named in the registryTaking people
- WoolloongabbaHospital not named in the registryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Spyre Therapeutics, Inc.
- Trial code
- NCT07012395EU 2025-521242-26-00
- Record updated
- 27 October 2026
- Original description
This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.Read full original descriptionShow less
Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis
This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.
Inclusion: Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening; Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis); Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2.
Exclusion: Failed 4 or more approved or investigational advanced therapy classes; Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined; Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and/or other conditions that will likely require surgery during induction.